CLASS II Drug recall · Reported 22 Feb 2023 · FDA Enforcement Report
Thiamine Hydrochloride 200 mg/ (100mg/mL), Riboflavin 2 mg recalled
McGuff Compounding Pharmacy Services is recalling Thiamine Hydrochloride 200 mg/ (100mg/mL), Riboflavin 2 mg/ (1mg/mL) Injection, FOR, distributed nationwide in the US. The recall was initiated on 8 Dec 2022 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0266-2023
- FDA event ID
- 91498
- Recalling firm
- McGuff Compounding Pharmacy Services, Santa Ana, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Dec 2022
- FDA classified
- 10 Feb 2023
- Reported
- 22 Feb 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 8 Dec 2022 | Recall initiated by company | |
| 10 Feb 2023 | Classified by FDA | +64 days |
| 22 Feb 2023 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Particulate Matter: Presence of foreign substances were reported in vials at the pharmacy.
Product as listed by the FDA
Thiamine Hydrochloride 200 mg/2mL (100mg/mL), Riboflavin 2 mg/2mL (1mg/mL) Injection, FOR INTRAMUSCULAR OR SLOW INTRAVENOUS USE, 2 mL Sterile Single Use Vial, Preservative-Free, Rx Only, Compounded for a licensed professional or patient use by: McGuff Compounding Pharmacy Services, Inc, Santa Ana, CA 92704.
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Presence of Particulate Matter: Presence of foreign substances were reported in vials at the pharmacy.
Which lots are affected?
Lot: 22K1681, initial BUD: 12/18/2022, extended BUD: 1/27/2023.
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 91498| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Thiamine Hydrochloride 3000 mg/ (100mg/mL) recalled | McGuff Compounding Pharmacy Services | Particulate Matter | Nationwide |
More recalls from McGuff Compounding Pharmacy Services
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Thiamine Hydrochloride 3000 mg/ (100mg/mL) recalled | McGuff Compounding Pharmacy Services | Particulate Matter | Nationwide |
| Drug | CLASS II | Dimercaptopropanesulfonate Sodium (DMPS) recalled | McGuff Compounding Pharmacy Services | Particulate Matter | 19 states |
| Drug | CLASS II | Lipoic Acid Injection (aka Alpha Lipoic Acid or Thioctic recalled | McGuff Compounding Pharmacy Services | Particulate Matter | Nationwide |
Other Thiamine recalls
All 14| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | thiamine HCl, 500 mg, 500 mg added recalled | Fresenius Kabi Compounding | Sterility | Nationwide |
| Drug | CLASS II | Thiamine HCl/Pyridoxine HCl 20 mg/mL /100mg/ml Injection recalled | AnazaoHealth | Particulate Matter | Nationwide |
| Drug | CLASS II | Thiamine Hydrochloride 3000 mg/ (100mg/mL) recalled | McGuff Compounding Pharmacy Services | Particulate Matter | Nationwide |
| Drug | CLASS II | Thiamine/ribofla/niacinami/dexpanth/pyridox/hydroxycobal recalled | Pharmacy Innovations | Sterility | Nationwide |
| Drug | CLASS III | Thiamine HCl Injection, USP 200 mg/ (100mg/mL) vials recalledThiamine Hydrochloride | Mylan Institutional | Packaging Defects | Nationwide |